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PrepaCyte® - CB

The simple solution for cord blood processing.

PrepaCyte®-CB

The simple solution for cord blood processing.

Intended Use

The PrepaCyte-CB (Cord Blood) Processing System is intended for use in cell processing laboratories to process and store total nucleated cells (TNC) from human umbilical cord blood, prior to banking.  The device is composed of three integrally-attached processing and storage containers (or a single processing container) with separation media. 

PrepaCyte-CB Quality

  • PrepaCyte-CB recovers high yields of TNCs, mononucleated cells (MNCs) and CD34+ progenitor stem cells from human umbilical cord blood, according to the results of BioE’s multi-site, in-vitro clinical study.
  • PrepaCyte-CB consistently removes approximately 99 percent of red blood cells (RBCs) from the final processed cord blood unit, according to BioE's clinical study. This benefit maximizes available cryopreservation space and reduces potential ABO incompatibility issues.
  • PrepaCyte-CB leaves desired TNCs and stem cells unmodified and unaffected during cord blood processing. 

PrepaCyte-CB Simplicity & Cost Effectiveness

  • PrepaCyte-CB is intuitive and easy-to-use, permitting rapid implementation within new and existing cord blood banks.
  • PrepaCyte-CB allows batch processing and reduces "hands on" staff time. Cryobanks International realized a time-savings of 50 minutes per cord blood unit using PrepaCyte-CB compared to its previous hetastarch processing method.
  • PrepaCyte-CB requires no costly capital equipment or maintenance fees. Only a standard laboratory centrifuge is required to concentrate desired cells after separation.
  • PrepaCyte-CB integrates with STEMSOFT Software Inc.’s StemLab to efficiently record, track and manage all associated cell processing and storage data.

Other PrepaCyte-CB Product Features

  • PrepaCyte-CB is a sterile device composed of three integrally attached processing and storage bags containing the PrepaCyte-CB separation solution. The system’s interconnected, closed-bag set limits cell manipulation and helps minimize environmental contamination and identification errors.
  • PrepaCyte-CB’s bag set and separation solution are shown to be non-toxic.
  • PrepaCyte-CB is manufactured under FDA current Good Manufacturing Practices (cGMP).

Expected Results

A multi-site in vitro clinical study was performed with PrepaCyte-CB (P/N PCB1000).  Study results are shown below for TNC and CD34+ stem cells.

Results for TNC were obtained using an automated hematology analyzer and include lymphocytes, monocytes, granulocytes, CD34+ hematopoietic stem / progenitor cells and nucleated red blood cells (nRBCs).  Functional CFU assays were performed as part of the device performance validation and results demonstrated that the recovered cells retain hematopoietic proliferative potential. 

Analysis was conducted on cord blood units (collected in CPD) meeting a pre-processing criteria for TNC of >900 x 106, cord blood unit volume >60 ml (without anticoagulant) and were processed within 48 hours of collection.

TNC absolute counts and recoveries were reported on 155 cord blood units; of the 155 units, absolute viable CD34+ counts and recoveries were reported on 73 units.

Data shows that:

§         100% (155/155) of cord blood units processed met the minimum TNC absolute count recommendation of = 5.0 x 108 TNC / unit HPC-C for a transplantable unit. (Based on 20kg recipient at = 2.5 x 107 nucleated cells/kg.)

§         100% (73/73) of cord blood units processed met the minimum viable CD34+ absolute count recommendation of = 1.25 x 106 CD34+ cells / unit HPC-C for a transplantable unit. 

Recommendations from FDA’s Draft Guidance document “Minimally Manipulated, Unrelated, Allogeneic Placental/Umbilical Cord Blood Intended for Hematopoietic Reconstitution in Patients with Hematological Malignancies”.

 

Flexible for Market Developments/Changes

PrepaCyte-CB is the first clinical product originating from BioE’s patented PrepaCyte technology platform.  This flexible platform can generate a variety of cell products, an important feature as other cell types emerge as clinically relevant.

Caution: Federal Law restricts this device to sale by or on the order of a licensed practitioner. 

 

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